The standards of care regarding the use of microkeratomes and microkeratome blades is the central issue in a pending class-action lawsuit that has been filed against LaserVue Eyecenter, its founder, Jay Bansal, MD, and his wife and partner, Swati Singh, MD. The case, which has received national media attention, came to light after a former employee alerted California public health officials that LaserVue physicians were using the same microkeratome blade on consecutive patients and reusing microkeratome heads, including suction rings, without autoclaving them between procedures.

The impending lawsuit against LaserVue has given refractive surgery a black eye, while shining a spotlight on a practice that some physicians say is commonplace around the world. In the lawsuit, filed last summer against LaserVue, attorneys for the plaintiffs assert "fraud, battery, and unfair competition in connection with the center's failure to properly sterilize equipment used to perform LASIK [laser in-situ keratomileusis]."

The suit alleges that Bansal and his associates "willfully and recklessly failed to sterilize the equipment used in the LASIK procedure, and willfully and recklessly reused unclean blades and other surgical products during the surgical procedures in an attempt to maximize their profits by saving expenses and by increasing the number of patients [they] are able to treat in an hour."

The primary concern expressed in the court documents is that the alleged actions may have exposed some of an estimated 2,700 patients and the public to the transmission of blood-borne and other infectious diseases, including HIV and hepatitis B and C. According to informed sources, two former LaserVue patients have tested positive for hepatitis, but it is not known whether they contracted the disease from the LASIK procedure. The attorney for the defense says that experts, including the California Department of Public Health, agree that the risk of any disease being transmitted through these practices was extremely low, and that patients need not be tested.

In September of last year, a preliminary injunction was issued prohibiting Bansal, Singh, and LaserVue Eye Center from conducting any LASIK procedures "without changing the microkeratome blade between procedures and sterilizing the microkeratome between procedures." However, LaserVue claims it voluntarily discontinued the challenged practices in May last year.

On advice of his counsel and because the matter is in litigation, Bansal has not responded to repeated requests for comment from EyeWorld. But, in court documents, he has admitted to reusing blades and microkeratome heads on two patients - after simply rinsing them with sterile water. In fact, the defendants in the LaserVue case do not dispute the fact that they used a single blade for two patients, provided that the first patient had no history of any infectious diseases, there was no bleeding, and the blade performed well. "When a blade was reused on a second patient, it was always cleaned with sterile water and allowed to dry," Bansal's attorneys said in a court filing.

"The standards of care for LASIK are still being worked out and no patients at LaserVue were harmed by this practice," said Fletcher C. Alford, Bansal's attorney. "We believe the evidence will clearly demonstrate that none of the patients experienced any injury whatsoever from the surgical techniques in question. ... From our perspective, this case was brought by several disgruntled employees."

The case against LaserVue became known when a former employee became aware that the center was reusing blades on more than one patient. Leah Holtan, who worked for LaserVue from October 1998 to June 1999, said in court documents, "I personally observed that LaserVue physicians Jay Bansal, MD, and his wife, Swati Singh, MD, did not sterilize the microkeratome between patients and did not change the blade between patients. The microkeratome and blade were reused for surgeries on later patients without sterilization." Holtan said she resigned from LaserVue because of the practice.

This March, the California Department of Health Services ordered LaserVue to notify all its LASIK patients treated between March 1996 and May 1999 that they may have been exposed to infectious diseases. "The procedures used at LaserVue Eye Centers were clearly not in compliance with established infection control recommendations for the disinfection and sterilization of patient-care items," said Jon Rosenberg, MD, a state epidemiologist. "The seriousness of the breaches in infection control practices were sufficient to warrant the notification of patients who had undergone these procedures and might have been exposed by contaminated equipment." Alford pointed out that the Department decided that the patients need not be tested for any infectious disease.

In a May 4 letter to patients, LaserVue admited reusing blades and microkeratomes after rinsing them with water. "The practice was to reuse a blade on a second patient if that blade proved satisfactory on the first patient. ... This reduced the risk that an unproven new blade might have an imperfection that could cause a corneal flap disorder," said the letter from LaserVue. "It was also the procedure to reuse the microkeratome assembly on up to four patients without heat sterilizing it."

EyeWorld has learned that the Medical Board of California is investigating Bansal, Kay, and Singh in connection with the lawsuit's allegations.

Still, there are varying opinions regarding just what the standard of care is in the United States when it comes to microkeratomes and blades.

Bausch & Lomb's Hansatome user's manual, which is being updated as a matter of regular policy, recommends for the disposal of microkeratome blades after each use. The maker of the world's mostly widely used microkeratome recommends a three-step process for cleaning and sterilizing heads between each LASIK procedure. After each use of a Hansatome microkeratome, the manufacturer's specifications call for the head to be soaked for 2 minutes in sterile distilled water containing a Food and Drug Administration-approved medical cleanser; scrubbed on all six sides with a soft-bristle toothbrush, thoroughly cleaning all open cavities (blade holder, flap slot); rinsed in a second bowl for 1 minute; and then soaked for 5 minutes in sterile distilled water; and rinsed for 1 minute in third bowl of sterile distilled water. Once the rinsing and cleaning are completed, Bausch & Lomb recommends autoclaving for between 3 and 30 minutes, depending upon the type of autoclave being used.

In a declaration on behalf of the defense, Ralph G. Berkeley, MD, clinical assistant professor, University of Texas, Houston, who helped train Bansal, said, "The rationale for reuse of blades has nothing to do with saving time or money."

Berkeley said that because the quality of the incision is so critical in LASIK, blade quality is of paramount concern. "Ophthalmologists who learned LASIK in the early years of the procedure were taught to reuse blades on multiple patients as a way of reducing flap complications," he said.

Because of concerns about blade quality, Berkeley said, many surgeons learned to reuse blades as a precaution. "It is my opinion that the procedures used by Dr. Bansal ... were not below the standard of care and were consistent with what many other reputable and experienced surgeons were doing," he said.

Another refractive surgeon, Alan B. Aker, MD, said in a declaration for the court, "I do believe that using a new blade and sterilizing the assembly for each patient is certainly a good change, but it is not currently in practice throughout the United States or Canada or the rest of the world."

Other physicians argue that the standard of care in the United States is to use a fresh blade on each patient and to autoclave the microkeratome head after each use. Gary M. Kawesch, MD, a refractive surgeon who also practices in the Bay area, said LaserVue's microkeratome sterilization process and reuse of blades are not in keeping with the accepted standard of care in the United States. "The standard of care is a new blade and a fresh, sterilized keratome for each patient," he said. "Blades get dull with use, and every doctor knows there is 'invisible' blood, tissue, and fluid that can contaminate a blade or microkeratome."

Kawesch estimated that maybe one in 1,000 blades is defective and that those defects can be seen during routine preoperative inspection. Moreover, he said, microkeratome assemblies should be autoclaved for 5 minutes after each use. In his practice, Kawesh rotates three microkeratomes in and out of service to reduce operating room downtime.

By reusing blades, Kawesch said, LaserVue may simply have been trying to save money. Assuming a patient flow of 300 patients a month and a blade cost of $50 each, total blade costs should have been about $15,000 a month. By reusing the same blade on two patients, the center would have saved $7,500 a month. Moreover, by not investing in additional microkeratome units or heads, the center would have realized additional savings. However, Bansal's counsel has indicated in court documents that LaserVue always had at least two microkeratomes available on surgery day, so that there would have been no money-saving motivation for his practices.

Stephen D. McLeod, MD, a refractive surgeon and assistant clinical professor at the University of California, San Francisco, agreed that LaserVue's practice is not consistent with the standard of care. "I personally advocate changing the blade between each patient," McLeod said. "My own practice is to change the blade between eyes of each patient; I demand a pristine cut each time, and there is evidence that the blade dulls after even one use."

While different manufacturers have varying recommendations for microkeratome sterilization, McLeod said that it is critical to sterilize the microkeratome head into which the blade fits. "As a general rule, all nondisposable microkeratome heads can be autoclaved and should be between all patients," he said. "We have three nondisposable microkeratome bodies and five heads, so I use a freshly autoclaved head for each eye of each patient."

In his supporting declaration filed on behalf of the plaintiffs, August L. Reader III, MD, associate clinical professor, University of Southern California, San Francisco, said, "In LASIK procedures, it is beneath the standard of care to fail to change the blades in the microkeratomes between patients. It is also beneath the standard of care to not sterilize the microkeratome between patients. The standard of care requires that the microkeratome be sterilized in an autoclave between each patient. ... The failure to properly sterilize the equipment between patients can result in the transfer of diseases between patients."

In another filing on behalf of the plaintiffs, Joseph B. Marzouk, MD, chief of the infectious disease service at Summit Medical Center in Oakland, Calif., said, "Because of the lack of sterilization of surgical instruments, there has potentially been the transmission of bodily fluids, which includes blood, from one LaserVue patient to another."

"Of particular concern," McLeod said, "is virus in tear film, including hepatitis. Also, bleeding might occur in patients with pannus - not uncommon in longtime contact lens wearers - and so direct blood-to-blood transmission can theoretically occur. Based on corneal transplant data, corneas have transmitted rabies, Creutzfeldt-Jakob disease, hepatitis B, cytomegalovirus, herpes simplex virus, bacteria, and fungi. While this may well be due to the higher risk posed by cell-to-cell transmission made possible by whole-tissue transplantation, cellular fragments adherent to the blade or tear film contamination pose an unknown risk."

Certification of the class-action status of the lawsuit against LaserVue was pending when EyeWorld went to press. Among the grounds for challenging certification of the class identified by the lawsuit is the fact that Barry S. Kay, MD, a former partner at LaserVue, is not named as a defendant in the action - although he treated more than 1,000 of the potential plaintiffs. Approximately five former LaserVue patients currently are part of the case out of an estimated 2,700 patients who were treated during the time LaserVue was reusing its blades and microkeratome assemblies. According to informed sources, the parties involved in the case, including Bansal's malpractice insurance company, are involved in settlement discussions.

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